Evaluating Upadacitinib with Corticosteroids for Children with Atopic Dermatitis

A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety and Efficacy of Upadacitinib in Combination With Topical Corticosteroids in Children From 2 to Less Than 12 Years of Age in Japan With Moderate to Severe Atopic Dermatitis

This study is testing if a new medication combined with skin creams can help children aged 2 to under 12 with severe eczema feel better.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 98 (estimated)
• Ages: 2 Years to 11 Years
• Sex: All
• Sponsor: AbbVie (Industry-sponsored)
• Drugs / interventions: upadacitinib
• Locations: 25 sites (Nagoya-shi, Aichi and 24 other locations)
• Trial ID: NCT06701331 on ClinicalTrials.gov

What this trial studies

This clinical trial assesses the safety and efficacy of upadacitinib, a medication approved for treating moderate to severe atopic dermatitis in older patients, when combined with topical corticosteroids in children aged 2 to less than 12 years in Japan. The study involves a 35-day screening period followed by a 12-week randomized, double-blind treatment phase where participants have a 50% chance of receiving a placebo. After this, there will be an open-label treatment phase lasting up to 52 weeks. Approximately 98 participants will be enrolled across 35 sites in Japan.

Who should consider this trial

Good fit: Ideal candidates are children aged 2 to 11 years with moderate to severe atopic dermatitis who have not responded adequately to topical treatments.

Not a fit: Patients with mild atopic dermatitis or those who have not previously used topical corticosteroids may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the management of moderate to severe atopic dermatitis in young children.

How similar studies have performed: Previous studies have shown positive outcomes with upadacitinib in older populations, but this specific approach in younger children is novel.

Eligibility criteria

Inclusion Criteria:

* A minimum weight of 10 kg and weight and height ≥ -2.0 SD for their age according to Japanese standard growth charts at the Baseline visit.
* Atopic Dermatitis (AD), according to Hanifin and Rajka criteria, with onset of symptoms at least 6 months prior to Baseline.
* Eczema Area and Severity Index (EASI) score ≥ 16; validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) score ≥ 3; ≥ 10% body surface area (BSA) of AD involvement at the Baseline visit; and Baseline weekly average of daily WIS or WSI-NRS ≥ 4.
* Participant has applied a topical, additive-free, bland emollient or moisturizer twice daily for at least 7 days before the Baseline visit.
* Documented history (within 6 months of the Baseline visit) of inadequate response or intolerance to topical corticosteroids (TCS) and/or topical calcineurin inhibitors (TCI) or a systemic immunomodulating therapy, or medical inadvisability of available systemic therapy (e.g., because of important side effects or safety risks).

Exclusion Criteria:

* Participants that have current and/or history of other active skin diseases (e.g., psoriasis or Netherton syndrome or lupus erythematosus) or skin infections (bacterial, fungal, or viral) requiring systemic treatment within 4 weeks of the Baseline visit or that would interfere with the appropriate assessment of AD lesions.
* Participants that have used topical treatments for AD (except for topical emollient or moisturizer treatments) including but not limited to TCS, TCI, or topical PDE-4 inhibitors, within 7 days of the Baseline visit or any the following prohibited AD treatments within the specified timeframes below prior to the Baseline visit:

  * Systemic therapy for AD, including but not limited to corticosteroids and cyclosporine, within 4 weeks;
  * Targeted biologic treatments within 5 half-lives (if known) or within 12 weeks, whichever is longer;
  * Phototherapy treatment, laser therapy, tanning booth use, or extended sun exposure that could affect disease severity or interfere with disease assessments within 4 weeks.

Where this trial is running

Nagoya-shi, Aichi and 24 other locations

• Central Clinic /ID# 269205 — Nagoya-shi, Aichi, Japan (Recruiting)
• Fujita Health University Hospital /ID# 269201 — Toyoake, Aichi, Japan (Recruiting)
• Miyata Dermatology Clinic /ID# 269200 — Matsudo-Shi, Chiba, Japan (Recruiting)
• Hoshikuma Dermatology ・ Allergy Clinic /ID# 270192 — Fukuoka-shi, Fukuoka, Japan (Recruiting)
• Saruta Dermatology Clinic /ID# 270416 — Fukuoka-shi, Fukuoka, Japan (Recruiting)
• Tokunaga Skin Clinic /ID# 270189 — Kasuga-shi, Fukuoka, Japan (Recruiting)
• Hospital of the University of Occupational and Environmental Health, Japan /ID# 269206 — Kitakyushu-shi, Fukuoka, Japan (Recruiting)
• Gunma University Hospital /ID# 272319 — Maebashi, Gunma, Japan (Recruiting)
• Sapporo Shiroishi Dermatology Clinic /ID# 269691 — Sapporo-shi, Hokkaido, Japan (Recruiting)
• Hirase Allergie Children's Clinic /ID# 271208 — Kobe, Hyogo, Japan (Recruiting)
• University of Tsukuba Hospital /ID# 271238 — Tsukuba-shi, Ibaraki, Japan (Recruiting)
• Ryuseidai Children's Clinic /ID# 271400 — Tsukuba, Ibaraki, Japan (Recruiting)
• Takeoka Dermatology Clinic /ID# 269199 — Marugame, Kagawa, Japan (Recruiting)
• Musashikosugi Sasamoto Pediatric and Allergy Clinic /ID# 270381 — Kawasaki-shi, Kanagawa, Japan (Recruiting)
• National Hospital Organization Sagamihara National Hospital /ID# 271575 — Sagamihara, Kanagawa, Japan (Recruiting)
• Aoi Dermatology Clinic /ID# 274265 — Kamimashiki-gun, Kumamoto, Japan (Recruiting)
• Medical corporation Kojinkai Yoshioka Dermatology Clinic /ID# 269198 — Neyagawa-shi, Osaka, Japan (Recruiting)
• Hayami Dermatology Clinic /ID# 269945 — Osaka-shi, Osaka, Japan (Recruiting)
• Momodani Skin Clinic /ID# 270384 — Osaka-shi, Osaka, Japan (Recruiting)
• Medical corporation Jun Dermatology Clinic /ID# 269953 — Osaka-shi, Osaka, Japan (Recruiting)
• Dermatology and Ophthalmology Kume Clinic /ID# 271854 — Sakai City, Osaka, Japan (Recruiting)
• Dokkyo Medical University Hospital /ID# 270367 — Mibu, Tochigi, Japan (Recruiting)
• Fukuwa clinic /ID# 269203 — Chuo-ku, Tokyo, Japan (Recruiting)
• Seijo Sasamoto Pediatric Allergy Clinic /ID# 270194 — Setagaya-ku, Tokyo, Japan (Recruiting)
• Saitama City Hospital /ID# 271392 — Saitama, Japan (Recruiting)

Study contacts

• Study coordinator: Abbvie Call Center

Conditions Atopic Dermatitis; Upadacitinib